| Properties | Details |
|---|---|
| SFDA Classification | Class iii |
| Purpose of Use | A device that allows the Surgeon to precisely track the location and then project the instrument on it. It is done based on a CT image. |
| Work Location & End-User | Work Location: Operation Room. End-User: Surgeon, Nurse. |
| Parts & Accessories | • A computer platform with screen • Respective Navigation Software • Surgical instruments and tracers. |
| Operation | Surgical navigation systems use instruments, sensors, and trackers to determine and allow for real-time tracking of the exact location. During the surgery, the marker sensor is attached to the patient as a reference to enable an exact localization in space, and the surgical instruments used are connected to the surgical navigation device. In some models, the patient needs to go under CT to take an exact image of the part. Then, the map of the image is loaded to the navigation system software that processes the images and collects positional data from the tracking system. |
| Common Problems | • Connection problems • Registration problems for the trackers and the instruments. |
| Manufacturers | • Medtronic • Karl Storz se & Co. KG • B. Braun. |
| Sources | • Saudi Food and Drug Authority • NCBI • The University of Texas Health Science Center at Houston (UTHealth) • GlobeNewswire |
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